title: Impact of age on the efficacy and safety of extended-duration thromboprophylaxis in medical patients. Subgroup analysis from the EXCLAIM randomised trial.
abstract: The EXCLAIM study enrolled hospitalised acutely ill medical patients with age >40 years and recently-reduced mobility into a trial of extended-duration anticoagulant thromboprophylaxis. This post-hocanalysis evaluated the impact of age on patient outcomes. After completion of open-label therapy with enoxaparin 40 mg once-daily (10 ± 4 days), eligible patients underwent randomisation to receive double-blind therapy of enoxaparin (n=2,975) or placebo (n=2,988) for 28 ± 4 days. During follow-up, the venous thromboembolism (VTE) risk increased with age in both treatment groups. In patients with age >75 years, those who received extended-duration enoxaparin had lower incidence of VTE (2.5% vs 6.7%; absolute difference [AD] [95% confidence interval]: -4.2% [-6.5, -2.0]), proximal deep-vein thrombosis (2.5% vs 6.6%; AD -4.1% [-6.2, -2.0]), and symptomatic VTE (0.3% vs 1.5%; AD -1.2% [-2.2, -0.3]), in comparison to those who received placebo. In patients with age ≤75 years, those who received enoxaparin had reduced VTE (2.4% vs 2.8%; AD -0.4% [-1.5, 0.7]) and symptomatic VTE (0.2% vs 0.7%; AD -0.6% [-1.0, -0.1]) in comparison to those who received placebo. In both age subgroups, patients who received enoxaparin had increased rates of major bleeding versus those who received placebo: age >75 years (0.6% vs 0.2%; AD +0.3% [-0.2, 0.9], respectively); age ≤75 years (0.7% vs 0.2%; AD +0.5% [0.1, 0.9]). Patients in both age subgroups that received enoxaparin had similar low bleeding rates (0.6% and 0.7%, respectively). VTE risk increased with age, though the bleeding risk did not. Patients with age >75 years had a more favourable benefit-to-harm profile than younger patients.
authors.affiliation: Roger D. Yusen, MD, MPH, Washington University School of Medicine, Campus Box 8052, 660 S. Euclid Ave, St Louis, MO 63110, USA, Tel.: +1 314 454 8764, Fax: +1 314 454 5571, E-mail: ryusen@dom.wustl.edu.
authors.forename: Roger D
authors.initials: RD
authors.lastname: Yusen
authors.forename: Russell D
authors.initials: RD
authors.lastname: Hull
authors.forename: Sebastian M
authors.initials: SM
authors.lastname: Schellong
authors.forename: Victor F
authors.initials: VF
authors.lastname: Tapson
authors.forename: Manuel
authors.initials: M
authors.lastname: Monreal
authors.forename: Meyer-Michel
authors.initials: MM
authors.lastname: Samama
authors.forename: Min
authors.initials: M
authors.lastname: Chen
authors.forename: Bruno
authors.initials: B
authors.lastname: Deslandes
authors.forename: Alexander G G
authors.initials: AG
authors.lastname: Turpie
mesh_terms: D000367:Age Factors; D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D002170:Canada; D017984:Enoxaparin / Q000008:administration & dosage / Q000009:adverse effects; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000453:epidemiology* / Q000209:etiology / Q000517:prevention & control; D006801:Humans; D008297:Male; D008875:Middle Aged; D044382:Population Groups; D012307:Risk Factors; D013927:Thrombosis / Q000150:complications / Q000453:epidemiology* / Q000517:prevention & control; D013997:Time Factors; D014481:United States; D054556:Venous Thromboembolism / Q000453:epidemiology* / Q000209:etiology / Q000517:prevention & control
chemical_list: D000925:Anticoagulants; D017984:Enoxaparin
keywords: Venous thromboembolism; deep-vein thrombosis; enoxaparin; pulmonary embolism; thromboprophylaxis